CANDELA GENTLEMAX FAMILY OF LASERS


Device Classification Name

powered laser surgical instrument

510(k) Number K112715
Device Name CANDELA GENTLEMAX FAMILY OF LASERS
Applicant
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Applicant Contact sam wade
Correspondent
CANDELA CORP.
530 boston post road
wayland, 
MA 
01778

Correspodent Contact sam wade
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/19/2011
Decision Date 10/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No